HCV Self-testing in Pakistan

NCT04971538 | Unknown

• 1 other identifier: HC023
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

To achieve the goal of elimination of hepatitis C infection in Pakistan, the strategy of elimination needs to be increasingly directed towards case finding through mass screening in rural or peri-urban communities to identify and treat those not yet aware of their infection. Self-testing (ST) with easy-to-use rapid diagnostic tests has been successfully used for diseases such as HIV. The availability of self-testing has been shown to increase testing rates and testing acceptability in diverse populations around the world, in large part due to its convenience and privacy advantages. In the present study we aim to evaluate the acceptability and impact of a program enabling home delivery of hepatitis C virus (HCV) self-testing in the Malir district, Karachi division, Pakistan.

Conditions

Hepatitis C; Diagnostic Self Evaluation

Keywords

self-test; micro-elimination; house to house screening

Outcome Measures

Primary Outcomes (2)

• To assess the impact of HCV self-testing home delivery on HCV antibody testing rates

  The number of participants who report completing the HCV antibody testing in the intervention group.

  2 weeks to 2 months after enrollment

• To assess the impact of HCV self-testing home delivery on HCV antibody testing rates

  To assess that the proportion of participants who report completing the HCV antibody testing in the intervention group is superior to that of the participants in the control group by a margin of 20%.

  2 weeks to 2 months after enrollment

Secondary Outcomes (2)

• To assess the impact of HCV self-testing on the number of HCV antibody positive individuals who are aware of their status

  2 weeks to 2 months after enrollment

• To assess the cost of HCV self-testing

  entire duration of study, estimated 6 months

Study Arms (2)

HCV self-testing

EXPERIMENTAL

the study staff will leave an HCV ST and instructions for use (IFU) with the household. The study team will also explain the HCVST process to the most senior member of the household, as well as leave a mobile number for the participant to contact for help conducting the test. The study team will follow up with the participant to inquire about if testing was completed, collect any testing results, and conduct a brief survey.

Diagnostic Test: OraQuick® HCV Self-Test

Referral to clinic for HCV RDT

NO INTERVENTION

the study staff will leave information on HCV testing and direct them to the nearest clinic with screening services, the participant will not be left a HCVST. Study staff will also leave a mobile number for the participant to contact for further information on HCV testing. The study team will follow up with the participant to inquire about if testing was completed, collect any testing results, and conduct a brief survey

Interventions

OraQuick® HCV Self-Test DIAGNOSTIC_TEST

The OraQuick® HCV Self-Test is a lateral flow rapid diagnostic that can detect anti-HCV antibodies in oral fluid. Instructions for Use (IFU) for OraQuick® HCV Rapid Antibody Self-Test have been developed in Georgian for the previous 2 studies conducted in Georgia using the OraQuick® HCV Rapid Antibody Self-Test. The IFU has been optimized taking in the feedback on the IFU resulting from the aforementioned studies. As this HCV test is not approved for self-test use in Georgia, all tests will be labelled as Research Use Only (RUO) and test results will not be used for patient management.

HCV self-testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Residing in UC 9 or 10

You may not qualify if:

• Known to be HCV antibody positive
• Tested for HCV within the last 6 months
• At home during the visit by AKU staff for this study and available to be tested by study staff with an onsite RDT

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead
• Aga Khan University: collaborator

Study Sites (1)

Aga Khan University

Karachi, Sindh, Pakistan

RECRUITING

Related Publications (1)

• Shilton S, Ali D, Hasnain A, Abid A, Markby J, Jamil MS, Luhmann N, Nabeta P, Ongarello S, Reipold EI, Hamid S. Protocol for a cluster randomised controlled trial of secondary distribution of hepatitis C self-testing within the context of a house-to-house hepatitis C micro-elimination programme in Karachi, Pakistan. BMC Public Health. 2022 Apr 9;22(1):696. doi: 10.1186/s12889-022-13125-9.

  PMID: 35397544 DERIVED

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Saeed Hamid

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonjelle Shilton

CONTACT

+41 (22) 710 05 90; Sonjelle.Shilton@finddx.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a matched cluster randomized controlled study, the households in the intervention clusters will be left information on the importance of testing, an HCV self-test and instructions for use while the households in the control clusters will be left information on the importance of testing for HCV and information on how to get tested at the nearest facility.

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 21, 2021
• Study Start: November 29, 2021
• Primary Completion: March 1, 2022
• Study Completion: April 1, 2022
• Last Updated: February 28, 2022

Record last verified: 2022-02

Locations

PA (1)